Status:
COMPLETED
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Leukemia, T-Cell
Lymphoma, T-Cell, Cutaneous
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL...
Detailed Description
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL...
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL).
Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required.
All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.
All forms of ATL eligible, including the "smoldering" type as well as aggressive disease.
No symptomatic CNS disease other than tropical spastic paraparesis.
Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate).
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy:
CTCL must have failed initial chemotherapy.
ATL may or may not have had prior chemotherapy.
At least 4 weeks since prior cytotoxic chemotherapy.
Endocrine Therapy: Not specified.
Radiotherapy: At least 4 weeks since prior radiotherapy.
Surgery: Not specified.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: Not specified.
Life expectancy: Greater than 1 month.
Hematopoietic: WBC at least 3,000, Platelets at least 75,000.
Hepatic: Not specified.
Renal: Not specified.
Other:
No pregnant women.
Negative pregnancy test required of fertile women.
Key Trial Info
Start Date :
December 1 1989
Trial Type :
INTERVENTIONAL
End Date :
October 1 2000
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00001249
Start Date
December 1 1989
End Date
October 1 2000
Last Update
March 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892